(136 days)
No
The summary describes a mechanical implant (patellar component) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The focus is on the physical design, materials, and intended surgical use.
Yes.
The device is intended to treat various medical conditions affecting the knee, including degenerative joint disease, rheumatoid arthritis, fractures, and complications from failed prostheses, which are all therapeutic indications.
No
Explanation: The device is a patellar component for a knee replacement system, intended for treatment of various knee conditions and revision procedures. Its purpose is to replace or augment a patella, not to diagnose a condition.
No
The device description clearly states it is a "modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium alloy suture ring and the current commercially available Continuum® Patella," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a physical implantable device – a patellar component for knee replacement surgery. It is a modular porous-backed patella intended to be surgically implanted into the patient's knee.
- Intended Use: The intended use clearly states it's for surgical procedures to treat various knee conditions and complications from failed prostheses. This involves direct interaction with the patient's body during surgery, not testing samples outside the body.
The description, intended use, and lack of any mention of testing biological samples all indicate that this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.
This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.
Product codes
JWH
Device Description
The Revision Hedrocel® Patella is a modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium alloy suture ring and the current commercially available Continuum® Patella. The Revision Hedrocel® Patella provides the surgeon a method for augmenting defects in the patella typically encountered during revision surgery of the knee.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patella, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on similarities in design of the Revision Hedrocel® Patella and the predicate devices, the performance testing submitted in K882322 and K971879, and Hedrocel® materials' data found in MAF #920, supports the conclusion that the device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
3/15/99
K98 3835
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REVISION HEDROCEL® PATELLA
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert Poggie, PhD or John Schalago, RAC |
| Phone Number: | (201) 818-1600 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | October 29, 1998 |
| Device Trade Name: | Continuum Patella-Revision Hedrocel® |
| Device Common | |
| Name: | Prosthesis, Patellar |
| Classification Name: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer |
| Semi-Constrained Cemented Prosthesis | |
| Predicate Device(s): | Patellar Component of Continuum Knee System |
| (CKS), Implex Corp. (K882322); Continuum Porous | |
| Patella, Implex Corp. (K971879), Konstruct Patellar, | |
| Biomet, Inc. (K960856) | |
| Device Description: | The Revision Hedrocel® Patella is a modular porous |
| backed patella consisting of a Hedrocel® Patellar | |
| Backing with titanium alloy suture ring and the current | |
| commercially available Continuum® Patella. The | |
| Revision Hedrocel® Patella provides the surgeon a | |
| method for augmenting defects in the patella typically | |
| encountered during revision surgery of the knee. | |
| Intended Use: | The Implex Revision Hedrocel® Patella is intended |
| as the patellar component of the Continuum Knee | |
| System whose indications for use include: 1) | |
| noninflamatory degenerative joint disease including | |
| osteoarthritis or traumatic arthritis, 2) rheumatoid | |
| arthritis, 3) correction of functional deformity, 4) | |
| revision procedures where other treatments or | |
| devices have failed, 5) treatment of fractures that are | |
| unmanageable using other techniques, and 6) comp- | |
| Intended Use | |
| (continued) | This device is intended for use with bone cement and |
| supplemental fixation by means of suture attachment. | |
| Supplemental suture attachment may be used in | |
| cases where additional device support can be | |
| obtained. | |
| Device | |
| Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Device(s): | The materials, design and articulating surface |
| geometry of the Revision Hedrocel® Patella is similar | |
| and/or identical to the claimed predicate devices from | |
| Implex Corp. and Biomet Inc. | |
| Performance Data: | Based on similarities in design of the Revision |
| Hedrocel® Patella and the predicate devices, the | |
| performance testing submitted in K882322 and | |
| K971879, and Hedrocel® materials' data found in | |
| MAF #920, supports the conclusion that the device | |
| will perform as intended. | |
| Conclusion: | The Revision Hedrocel® Patella is substantially |
| equivalent to the predicate devices in terms of | |
| intended use, safety, and effectiveness. |
1
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
K983835 Re: Implex Revision Hedrocel® Patella Trade Name: Regulatory Class: II Product Code: JWH Dated: January 21, 1999 Received: January 22, 1999
Dear Dr. Poggie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Robert A. Poggie, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Implex Revision Hedrocel® Patella
Indications For Use:
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.
This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Pcolleto
(Division Sign-Off)
Division of General Restorative Devices K98382
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR ...
Over-The-Counter Use
μs
(Optional Format 1-2-96)
(Division Sign-Off)